FREQUENTLY ASKED QUESTIONS

FAQ'S - MEDICAL DEVICES

33. What is a “new” medical device?

Answer. A new medical device is one which does not have a predicate medical device registered / approved in India.

34. What is a “predicate” medical device?

Answer. A predicate medical device is one which is registered / approved in India and has the same indications/ intended use, material of construction and design characteristics as the device which is proposed for registration in India.

35. Who will issue Form-9 the manufacturer or the Principle Indian Agent? Ans.Form-9 can be issued by either the manufacturer OR the Principle Indian Agent.

36. How should the documents be notarized?

Answer. The notary should ensure that documents are properly authenticated by signing each document/page or by providing notarization page (Declaration from notary) having name/number of certificate/documents along with pages eg. This part includes certificate X (pages), Certificate Y (pages) etc. and should be intact (Authorized by notary tamper proof) and stapling or pasting not accepted.

37. What is the time limit for submission of Query Response?

Answer. 45 days from the date of issuance of a query or an extension can be sought with justification for delay.

38. Whether shelf life of the device can be stated on the label instead of date of manufacture?

Answer. Yes

39. If my medical device has an adverse event, do I need to report it to CDSCO?

Answer. Yes, this needs to be reported to the CDSCO.

40. If a recall or corrective action is required for my medical device, do I need to report it to the CDSCO?

Answer. Yes

41. Can an importer import a registered notified medical device having residual shelf life less than 60 % for Commercial or testing purpose?

Answer. No, as per the Rule (31) the residual shelf life at the time of import should be >60%.

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